OBJECTIVES:Clinical trials restricted to moderately active RA are limited. Filgotinib is approved for treating moderate to severe active RA. This post hoc analysis assessed the efficacy and safety of filgotinib in moderately active RA. METHODS:In FINCH 1, patients with active moderate to severe RA and inadequate response to methotrexate received filgotinib 200 mg or 100 mg (FIL200/FIL100) once daily, adalimumab 40 mg every 2 weeks or placebo, all with methotrexate (N = 1755). This subgroup analysis was conducted in patients with a moderate baseline Disease Activity Score in 28 joints using C-reactive protein [DAS28-CRP; >3.2 to ≤5.1; n = 425 (24.2%)]. RESULTS:A higher proportion of patients achieved DAS28-CRP <2.6, Clinical Disease Activity Index (CDAI) remission (≤2.8), low disease activity (LDA) (DAS28-CRP ≤3.2 or CDAI ≤10) and American College of Rheumatology (ACR20/50/70) responses with FIL200 and FIL100 vs placebo at weeks 12 and 24. Week 12 ACR20 response rates (primary end point) were 77.9%, 67.8% and 43.8%, respectively. A total of ∼75% of patients achieved DAS28-CRP LDA by week 24 with either filgotinib dose. FIL200 and FIL100 elicited greater improvements in patient-reported outcomes than placebo. The efficacy of filgotinib, maintained through week 52, was comparable to that of adalimumab. Frequency of adverse events (AEs) was similar with filgotinib and adalimumab. Infections were the most common AEs; incidence rates were 40-53% in active treatment groups. CONCLUSION:In this subpopulation with moderately active RA, the efficacy and safety of filgotinib were similar to those in the overall FINCH 1 population (patients with active moderate to severe RA). TRIAL REGISTRATION:ClinicalTrials.gov, http://clinicaltrials.gov, NCT02889796.
Educating patients about the drugs they take is essential for them to take them safely and effectively. This education is now commonly given by nurses as part of the huge expansion in the nurse specialist role. However, training for this role has not kept pace with practice. Nurses have expressed variable confidence in this role and expressed a wish for more formal training. Current practice often puts the information rather than the patient at the centre of the consultation with the nurse dominating the conversation. Cues to address the patient agenda are commonly missed. An animated patient who interrupts is probably not having their educational needs met. Education of the professionals around how to perform this task in an optimal way is necessary and should result in better efficacy and safety of the drugs. This could be achieved by incorporating features of Shared Decision Making and the Calgary-Cambridge consultation techniques into training and the consultation. Personalization by attention to patient preferences, language and health literacy is essential.
BackgroundThe effects of the menopause have received a lot of attention in the press recently. Anecdotally, patients report changes in their arthritis around the menopause, either onset or aggravation of symptoms. Clearly, there are hormonal influences on arthritis with the female predominance, onset of RA around times of hormonal change and improvement during pregnancy. We were interested in exploring the patient perspective to inform future research and educational needs.MethodA national survey was organised through the National Rheumatoid Arthritis Society (NRAS), using their database of people with RA and online community who self-selected as peri menopausal, menopausal or post-menopausal. A questionnaire was developed by the steering group seeking responses on the effects of the menopause, changes in the arthritis at the time, use of hormone replacement therapy (HRT) and any discussions they had had with their healthcare providers. Free text comments were analysed qualitatively.ResultsA total of 779 people responded during September/October 2023. Respondents were 95% Caucasian mainly in their 50s with onset of menopausal symptoms in their 40s. 80% responded that their arthritis was worse during the menopause with 10% being much worse. 47% had taken HRT. Of these, 80% experienced an improvement in their menopausal symptoms and 30% had a moderate or large improvement in their arthritis symptoms. A standout statistic was that 93% of respondents had had no medical discussion about the menopause. For those who did, this was most frequently with the GP in relation to HRT and osteoporosis. 84% of participants felt that the rheumatology team should receive more education and training about the menopause in relation to RA. The qualitative analysis revealed several themes: Discussion about the menopause only occurred if the patient raised it. There was conflicting advice about HRT. There is overlap and confusion of symptoms between RA and the menopause. Participants expressed a perceived link between menopause and onset or deterioration of their arthritis. This study was long overdue.ConclusionsPatients perceive a strong association between the menopause and onset or deterioration of their arthritis, with confusion over what is due to arthritis and what is being caused by the menopause. Patients would like much more discussion about the menopause, but this is not currently happening. They are getting conflicting advice on HRT. Further research is necessary to clarify the impact of the menopause on people with arthritis.
Developing new drugs is extremely expensive often costing upwards of a billion dollars to bring a drug to market1. This is driven by the studies required to demonstrate the safety of the drug and bears little relation to the cost of manufacture. Demonstration of efficacy generally requires much smaller numbers. The level of safety required is, quite rightly, stringent, and is to give confidence that unexpected side effects are unlikely to be found when the drug is released for use in the general population. If a lower level of safety was accepted, then drugs could be considerably cheaper, but at a risk. However, the study patients are selected, usually for having active disease and few other conditions to complicate response. It is estimated that only about 30% of patients seen in clinic are suitable for any particular study2 so we can’t know for sure what will happen when it is available to the other 70%. This is a weakness of the evidence base3. Drugs are licensed on a risk benefit analysis by the drug regulators eg the MHRA. More recently, driven by the expense of new drugs, in the UK, before they can be used they have been required to show cost effectiveness through a National Institute for Clinical Excellence (NICE) assessment where the cost of the improvement in quality of life needs to hit an acceptable threshold4. There is often press and political interest in these approvals. The aim of NICE is to ensure value for money and equality of access to drugs, abolishing postcode prescribing where different geographical areas have different access to drugs. However, the Clinical Commissioning Groups (CCGs) who pay for the drugs, may have their own interpretation of guidelines, and NICE approvals, which apply in their area. An example of this was a restriction on the number of higher cost drugs (HCDs Biologics and JAKi) that could be tried for RA by a substantial number of CCGs in England5,6. At a session of the BSR annual meeting in 2019 discussing what Rheumatologists do when the patient in front of them doesn’t fit the guideline for a treatment that they think will be effective, it became apparent that a substantial number of rheumatology services were restricted by their CCGs7. Those of us from unrestricted areas were surprised and could not understand the logic for this restriction. The main reason discussed was that these drugs had not been shown to be cost-effective at higher choice points. That was, of course, true but only because the studies had not been done, another weakness of the evidence base3. Lack of evidence is not evidence of lack of effect.
INTRODUCTION:In 2020, almost half of all Clinical Commissioning Groups in England were restricting the number of higher cost drugs (HCDs) that could be prescribed for Rheumatoid Arthritis (RA) before an Individual Funding Request was required. We were interested in qualitatively exploring the experiences of prescribers affected by these restrictions and the experiences of patients who required four or more of these drugs.METHODS:Semi-structured interviews were conducted with five prescribers in restricted areas and six patients from our own service who had received four or more HCDs. The interviews were analysed thematically.RESULTS:Prescribers reported feeling distressed and frustrated by the unsatisfactory service they were constrained to provide. Some prescribers continued partially effective treatments in order not to run out of options. They did not find Individual Funding Requests or the Blueteq High Cost Drug (HCD) System helpful in the management of these patients. The Blueteq HCD System is an electronic platform that allows health managers to monitor the prescribing of high-cost medicines and manage the complexities associated with their use. Patients expressed severe distress at the prospect of running out of options and anxiety around the process of gaining approval for their next treatment.CONCLUSIONS:Restricting drugs for RA by the number which can be prescribed results in persistence with partially effective treatments, which is unsatisfactory for prescribers and patients, further it does not save money. Patients need to travel in their journey with RA and be able to try the next drug even though they know that it may not work.
Musculoskeletal CareVolume 21, Issue 3 p. 943-946 SHORT REPORT Restrictions on the use of higher cost drugs for rheumatoid arthritis in England: Surveys of Clinical Commissioning Groups; prescribers David Walker, David Walker orcid.org/0000-0002-4714-447X Research and Development, Northumbria Healthcare NHS Foundation Trust, North Shields, UKSearch for more papers by this authorJane Barry, Jane Barry Medical Affairs Department, Ireland Galapagos Biotech, Cambridge, UKSearch for more papers by this authorLaura Akroyd, Laura Akroyd Medical Affairs Department, Ireland Galapagos Biotech, Cambridge, UKSearch for more papers by this authorSandra Robinson, Corresponding Author Sandra Robinson [email protected] orcid.org/0000-0001-9960-8769 Research and Development, Northumbria Healthcare NHS Foundation Trust, North Shields, UK Correspondence Sandra Robinson. Email: [email protected]Search for more papers by this author David Walker, David Walker orcid.org/0000-0002-4714-447X Research and Development, Northumbria Healthcare NHS Foundation Trust, North Shields, UKSearch for more papers by this authorJane Barry, Jane Barry Medical Affairs Department, Ireland Galapagos Biotech, Cambridge, UKSearch for more papers by this authorLaura Akroyd, Laura Akroyd Medical Affairs Department, Ireland Galapagos Biotech, Cambridge, UKSearch for more papers by this authorSandra Robinson, Corresponding Author Sandra Robinson [email protected] orcid.org/0000-0001-9960-8769 Research and Development, Northumbria Healthcare NHS Foundation Trust, North Shields, UK Correspondence Sandra Robinson. Email: [email protected]Search for more papers by this author First published: 24 April 2023 https://doi.org/10.1002/msc.1767Citations: 1Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinkedInRedditWechat CONFLICT OF INTEREST STATEMENT The authors declare no conflicts of interest. Open Research DATA AVAILABILITY STATEMENT The data that support the findings of this study are available from the corresponding author upon reasonable request. REFERENCES Bakker, M. F., Jacobs, J. W., Kruize, A. A., van der Veen, M. J., van Booma-Frankfort, C., Vreugdenhil, S. A., Bijlsma, J. W. J., Lafeber, F. P. J. G., & Welsing, P. M. (2012). Misclassification of disease activity when assessing individual patients with early rheumatoid arthritis using disease activity indices that do not include joints of feet. Annals of the Rheumatic Diseases, 71(6), 830–835. 10.1136/annrheumdis-2011-146670 PubMedWeb of Science®Google Scholar Ciurtin, C., Brown, G., Cotton, A., Guinto, J., Jones, A., & Morris, V. (2017). THU0138 Das 28 correlated poorly with the objective evidence of inflammation as detected by ultrasound (US) examination of hands and feet in patients with established rheumatoid arthritis (RA). Google Scholar Mistry, J., Hill, D., Bosworth, A., & Kaul, A. (2021). P092 NICE biologics pathways for inflammatory arthritis exhibit regional variability due to modification by CCG's: Results from a national survey of pathways in England. Rheumatology, 60(Suppl 1), keab247-090. 10.1093/rheumatology/keab247.090 Web of Science®Google Scholar Smolen, J. S., Eberl, G., Breedveld, F. C., Jones, I., Leeming, M., Wylie, G. L., & Kirkpatrick, J. (1995). Validity and reliability of the twenty-eight-joint count for the assessment of rheumatoid arthritis activity. Arthritis & Rheumatism: Official Journal of the American College of Rheumatology, 38(1), 38–43. 10.1002/art.1780380106 CASPubMedWeb of Science®Google Scholar Walker, D., Goff, I., & Robinson, S. (2022). Real-world single-centre experience of rheumatoid arthritis patients requiring four or more higher cost drugs: Response and duration of treatment. Clinical Rheumatology, 41(9), 2695–2700. https://doi.org/10.1007/s10067-022-06232-w 10.1007/s10067-022-06232-w PubMedWeb of Science®Google Scholar Walker, D., Griffiths, B., Kiely, P., & Marzo-Ortega, H. (2020). What do UK Rheumatologists do when the patient doesn't fit the guideline for treatment? Rheumatology, 59(7), 1465–1466. 10.1093/rheumatology/keaa151 PubMedWeb of Science®Google Scholar Zhao, S., Kersley-Fleet, L., Bosworth, A., Watson, K., & Hyrich, K. (2022). Effectiveness of sequential biologic and targeted anti-rheumatic drugs for Rheumatoid Arthritis. Rheumatology, 61(12), 4678–4686. 10.1093/rheumatology/keac190 CASPubMedWeb of Science®Google Scholar Citing Literature Volume21, Issue3September 2023Pages 943-946 ReferencesRelatedInformation
DEAR EDITOR, Over the years there has been a history of drugs used for rheumatic conditions, which patients have found useful and which could be continued on an individual risk–benefit basis, being withdrawn from use. Sometimes this has been attributable to toxicity concerns for the user (e.g. lumiracoxib). Sometimes it has been for wider public health issues, such as toxicity in overdose (e.g. co-proxamol) [1]. For others, it has been a simple commercial decision by the manufacturer because it is no longer profitable to market (e.g. auranofin and benoral). It has been suggested that this should not be allowed under the licence and that supply should be maintained for patients who wish to continue and where their physician believes that the risk–benefit is in favour of continuing [2]. In 2019, i.m. gold was withdrawn worldwide. This, we were told, was because the raw materials were no longer available [3]. However, it seems inconceivable that there was not an economic factor in this decision. If we could make sodium aurothiomalate in the 1930s, then presumably we could still make it if there were to be sufficient incentive. Before the widespread use of MTX, i.m. gold was commonly used for the management of inflammatory arthritis [4]. Patients who were users of i.m. gold in 2019 had either been on it for many years (and for whom it was a very satisfactory drug) or they had been started on it more recently, chosen for its toxicity profile in patients who had failed many other drugs or because it was not subject to restrictive National Institute for Health and Care Excellence guidance To evaluate the effect of its withdrawal, we searched our departmental database in Northumbria Healthcare Trust for users of i.m. gold in July 2019 and recorded changes to their treatment regimen and disease control up to July 2021. From a cohort of 4750 (RA: 2500; PsA: 1700; axial spondylitis: 550), we identified 37 patients receiving gold: 32 for RA; 4 for PsA and 1 for axial spondylitis. Of these, 28 were taking gold as monotherapy (3 of whom also required regular CS) and the rest in combination with another DMARD (4 MTX, 3 SSZ, 1 LEF and 1 rituximab). Records of the indication for gold over alternatives were not available in all cases, but concern regarding frequent chest infections was a common theme and clearly documented as a contraindication to biologics in five cases. We attempted follow-up during autumn 2021, 2 years after withdrawal, to observe patient progress and changes in medication. Follow-up has been impacted by the coronavirus disease 2019 pandemic, with 11 patients yet to be reviewed since cessation of therapy. It is expected that this reflects the absence of flare in these cases, because the Northumbria Rheumatology service operates an effective emergency helpline. Amongst those taking gold as part of combination therapy, no new DMARDs have been initiated, and only one patient appeared to have a deterioration in disease control. Amongst the 28 patients receiving gold monotherapy, 13 have commenced new treatments, with 5 commencing biologic/targeted synthetic DMARDs. Of the remaining 15 patients, 3 have experienced a deterioration in their disease control requiring additional CSs but are yet to be established successfully on a replacement DMARD; 6 have stable disease, and 6 are yet to be seen. In total, 35% of patients commenced a new DMARD, and an additional 11% experienced a flare requiring CS. Reassuringly, however, over half the patients demonstrated stable disease in the absence of further therapy. This suggests that a proportion of patients on long-term treatments do not need them and highlights the need to consider treatment tapering or withdrawal in those with stable disease. This should be a shared decision between patient and physician, rather than a result of withdrawal by the manufacturer. However, almost half of our patients who were stable on i.m. gold have suffered increased disease activity or required a change of therapy as a result of this withdrawal, and some are still not on satisfactory replacement. With many superior agents available today, gold, appropriately, does not feature in modern treatment algorithms. However, it still proved to be very satisfactory drug for the small but significant proportion of patients taking it, some of whom struggle to find a suitable alternative. The regulators of the licensing of medications should consider the consequences of unilateral withdrawal and could perhaps prevent such occurrences in the future.
Educating patients about methotrexate is a core role of rheumatology nurses. We have previously reported the scoring of videoed interviews of rheumatology nurses educating patients prior to commencing methotrexate in comparison with the Calgary-Cambridge consultation model, and the qualitative analysis of the transcripts (Robinson et al. Musculoskeletal Care 2021). We were interested to investigate what could be learned from a more quantitative analysis of utterances and movements in these consultations and how they related to the qualitative interpretations. To investigate the frequency of utterances and body movements during interactions between rheumatology nurses and patients commencing methotrexate and to relate these to the qualitative interpretations of the interviews. Video-recordings of ten patients receiving methotrexate education from four different rheumatology nurses were available from the previous study. They were analysed using the Medical Interaction Process System (MIPS). This involved coding all utterances and body movements minute-by-minute by multiple inspections of the recordings. The first 10 min of each consultation was coded. The utterances and movements of the nurses and patients were compared. The thematic analysis based on the structure and content of the Calgary-Cambridge (C–C) consultation model was available from the previous study. This enabled the results from the MIPS to be compared between the interviews that scored higher on the C–C model and those scoring lower. The inter-rater reliability between 2 raters for one video was satisfactory (80–100
OBJECTIVES To evaluate efficacy and safety of filgotinib in Japanese RA patients who have failed or were intolerant to one or more biologic disease-modifying antirheumatic drugs (bDMARD) from the global FINCH 2 study (NCT02873936). METHODS This subgroup analysis was performed using the predefined statistical analyses. The FINCH 2 study is a randomized, double-blind, placebo-controlled, Phase 3 study in adult RA patients with inadequate response to bDMARDs. The randomized patients were treated with once-daily filgotinib 200 mg, filgotinib 100 mg or placebo on a background of csDMARDs for 24 weeks. RESULTS Of 449 patients enrolled in the overall population, 40 patients were enrolled from Japan. In the Japanese population, the American College of Rheumatology 20% response rates at week 12 (primary endpoint) were 83.3% and 53.3% for filgotinib, 200 mg and 100 mg, respectively, vs 30.8% for placebo. Filgotinib was well tolerated, similar to the overall population. CONCLUSIONS Both doses of once-daily filgotinib 200 mg and filgotinib 100 mg were effective, and generally well-tolerated in Japanese patients with active refractory RA.
Background The effects of filgotinib on patient-reported outcomes (PROs) from 3 trials in patients with active rheumatoid arthritis were investigated. Methods Methotrexate (MTX)-naïve patients received filgotinib 200 or 100 mg plus MTX (FIL200+MTX, FIL100+MTX), filgotinib 200 mg monotherapy (FIL200), or MTX monotherapy through 52 weeks (NCT02886728). Patients with inadequate response (IR) to MTX (MTX-IR) received FIL200+MTX, FIL100+MTX, adalimumab 40 mg +MTX (ADA+MTX), or placebo (PBO)+MTX (rerandomized to FIL200+MTX or FIL100+MTX at week 24) through 52 weeks (NCT02889796). Patients with IR to biologic disease-modifying antirheumatic drugs (bDMARD-IR) received FIL200 or FIL100 or PBO with background stable conventional synthetic (cs) DMARDs for up to 24 weeks (NCT02873936). PROs included Health Assessment Questionnaire-Disability Index (HAQ-DI), Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) physical/mental component summary (PCS/MCS), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis (WPAI-RA), and Patient Global Assessment of Disease Activity (PtGA). Data are reported as least-squares mean changes from baseline with standard error to the timepoint representing each study’s primary endpoint. All statistical comparisons are of filgotinib groups vs their respective control groups. Results At week 24, among MTX-naïve patients, change from baseline (standard deviation) in HAQ-DI was − 1.00 (0.03; P < 0.001) with FIL200+MTX, − 0.94 (0.04; P < 0.01) with FIL100+MTX, and − 0.91 (0.04; P < 0.05) with FIL200 alone compared with − 0.81 (0.03) with MTX alone. At week 12, among MTX-IR patients, change from baseline in HAQ-DI was − 0.69 (0.04; P < 0.001 vs PBO+MTX, P < 0.05 vs ADA) with FIL200+MTX, − 0.57 (0.04; P < 0.001 vs placebo) with FIL100+MTX, and − 0.60 (0.04) with ADA vs − 0.40 (0.04) with PBO+MTX. At week 12, among bDMARD-IR patients, change from baseline in HAQ-DI was − 0.50 (0.06; P < 0.001) with FIL200+csDMARD and − 0.46 (0.05; P < 0.001) with FIL100+csDMARD vs − 0.19 (0.06) with placebo+csDMARD. Changes in SF-36 PCS and MCS, FACIT-Fatigue, WPAI, and PtGA tended to favor filgotinib over PBO, MTX, and ADA. Greater proportions of patients experienced clinically meaningful differences with either dosage of FIL in combination with csDMARDs (including MTX) and with FIL200 monotherapy vs comparators. Conclusions Filgotinib provided improvements in PROs across patient populations. These findings suggest filgotinib can be an effective treatment option for patients with insufficient response to MTX or bDMARDs and patients who are MTX-naïve. Trial registration ClinicalTrials.gov , FINCH 1, NCT02889796 , first posted September 7, 2016; FINCH 2, NCT02873936 , first posted August 22, 2016, retrospectively registered; FINCH 3, NCT02886728 , first posted September 1, 2016, retrospectively registered.
Abstract Background/Aims Just under half of the clinical commissioning groups (CCGs) in England restrict the number of targeted therapies that can be prescribed for rheumatoid arthritis (RA) before an individual funding request (IFR) is required. We were interested to explore the impact of this on rheumatology services and rheumatologists themselves. Methods A national survey of rheumatologists who prescribe high-cost drugs was developed to explore prescribing restrictions by CCGs, the impacts on the service and the strategies adopted to mitigate this. Results from the survey were then used to develop an interview schedule for semi structured interviews with five rheumatologists to explore this in more detail. Results A total of 53 rheumatologists started the survey. 23 participants (44%) were restricted in their use of high-cost drugs. Restrictions were mainly by total number rather than mode of action. For 46, (88%) restrictions were communicated through local guidelines. 41% had additional local restrictions either through their pharmacy (5%), local pathways (10%) or a multi-disciplinary team meeting (MDT; 27%). 51% routinely discussed high-cost drugs with colleagues, with 21% discussing only complicated patients. The effect on the service was rated: a lot = 43%; moderately =24%; and a little or not = 7%. 95% said it affected their practice e.g., persisting with ineffective therapy. Blueteq was used by 69%; 29% were negative or very negative about it, 29% were neutral, and 23% were positive about it. 19% had it completed by someone else. Strategies for mitigating the restrictions included: 43% of participants had used a foot instead of a hand in the DAS28; 68% had changed diagnostic category to justify treatment; 51% had negotiated a local pathway. Three themes emerged from the semi-structured interviews. Theme 1) Persistence with partially effective therapy was used to avoid running out of options. There was genuine distress about the poor service that was being delivered. Theme 2) IFRs do not work but negotiating alternative pathways with the CCG can. Theme 3) Bluetec is an extra burden in the process but is OK if you do not have to fill it in yourself. Conclusion Restricting the number of targeted therapies that can be prescribed for RA has a detrimental effect on the service and the prescribers involved which often results in persistence with partially effective therapies. Continuing partially effective therapies is not satisfactory if there may be more effective therapies available. Acknowledgements: On behalf of the EVA-RA Joint Working Group. Disclosure D. Walker: Consultancies; Galapagos, Eli Lilly. S. Robinson: None.
Abstract Background/Aims Education of patients about their disease and treatments are a central part of the Nursing and AHP roles especially in chronic diseases such as arthritis. Different patients will require different approaches; layering and repetition of information are usually necessary. Recommended advice will also change over time with increased understanding and research, requiring updates for existing patients. In this situation any contact with the Rheumatology team is an opportunity to get health messages to patients. There is increasing data confirming the effect of obesity, exercise and smoking on response to treatment and outcomes in inflammatory arthritis. We were interested to explore if these messages had been delivered to established patients by our team. Methods We designed a short, self-complete, questionnaire for patients asking about information they had received from the team on lifestyle advice. We included questions on drug education as a positive control as we were confident that all patients would have received education about this. 50 consecutive patients with either rheumatoid or psoriatic arthritis seen by one consultant were included. Results The population was of 38 RA and 12 Psoriatic arthritis. Average duration of disease was 15yrs (Range 2-60). Average BMI was 28.4 (19.7-42.8). 29% were normal, 33% overweight and 38% obese. Only 59% said that they had moderate or a lot of education about their DMARDs and 11% reported having had none. However, 83% were moderately or very confident that they had sufficient information about the drug. No one reported no confidence. The most useful sources of information included the Doctors (50%) Nurses (37%) internet (24%) and booklets (9%). There was a strong correlation between amount of education and duration of disease (p < 0.001). Responses about how much information they had received from the team about lifestyle factors are shown in the table. There was a large range for all topics. Conclusion It appears that patients do not always remember education about their drugs, but all have confidence that they know about the drugs. Messages about lifestyle factors are being given by the “Team”, but around 50% of patients reported receiving little or no information on each topic. A more structured approach to these opportunities for education would be appropriate. Disclosure S. Robinson: None. M. Bourke: None. N. Scrafton: None. D. Walker: Consultancies; Galapagos, Eli Lilly.
The cost-effectiveness of higher cost drugs (HCDs) after several failures is disputed by some purchasers of services for people with rheumatoid arthritis (RA). We were interested to explore our service experience of using HCDs beyond the third choice to document response rates and duration of treatments. Records from our multi-disciplinary team meeting (MDT) that is used to decide on the use of HCDs were used to identify all RA patients who had been exposed to four or more HCDs. Notes were scrutinised for sequence of treatments, duration and response to treatments and reasons for stopping at each choice point. From a total of 2648 RA patients in our service, 49 (< 2%) had been exposed to four or more HCDs. Response rates based on descriptive assessments for fourth to sixth choices were between 50 and 55% as well as some partial responders. There were responders and failures to all drugs at every choice point. Patients who had responded to one drug were more likely to respond to the next. Patients often responded to drugs for approximately 2 years. Only four patients had stopped looking for the next HCD. Patients often respond to late choice HCDs. There are responders and failures at each time point and they are difficult to predict. There is no justification for restricting the number of HCDs that can be tried for RA.
Background/Aims It became apparent at a session at the BSR Annual Conference 2019 that some CCGs restrict the prescription of high cost drugs (HCDs) beyond three drugs for people with rheumatoid arthritis (RA). We were interested to explore the efficacy of HCDs beyond the third choice in our own service. Methods All patients in our service who are being considered for HCDs, are discussed at a multi-disciplinary team meeting comprising of seven consultants and eight nurses. The HCD decision is recorded in the minutes of the meeting which were scrutinised to identify patients who had received four or more HCDs. We began at March 2017, the launch of JAK inhibitors, in the expectation that few people would have had four HCDs before that time. The medical records were reviewed for the order of HCDs given and for evidence of efficacy and toxicity. The response to each drug choice was graded as: responder; partial responder and failure (primary non-responder or toxicity). Results From a database of 2,673 patients with RA, 542 patients were taking HCDs, thirty-two of those had received four or more of these drugs. Eleven of the thirty-two patients had tried four HCDs, seven had received five HCDs, ten patients had six, one patient had seven HCDs, two had tried eight and one patient had received nine HCDs. The response rates for each choice of drug are shown in table 1. Many patients responded to their fourth, fifth and sixth choice of HCD. If there was a restriction of three HCDs in our service, thirty-three prescriptions for drugs that patients have responded to, would not have been made. Conclusion Many patients responded to their fourth or subsequent HCD. Thus, there is no clinical justification in restricting the use of HCDs below at least six choices. Additionally, this data suggests that only small numbers of patients are prescribed more than four HCDs. Therefore lifting this limitation would have little cost implication. P141 Table 1:HCD Response RateHCD Choice*123456>6Responder12 (38%)10 (31%)10 (31%)12 (44%)14 (58%)6 (60%)1 (14%)Partial Responder5 (16%)1 (3%)7 (22%)5 (19%)4 (17%)1 (10%)1 (14%)Failure15 (47%)21 (66%)15 (47%)10 (37%)6 (25%)3 (30%)5 (71%)n =3232322724107*Switches to biosimilars were not regarded as a change. Disclosure D. Walker: Honoraria; Gilead Sciences Ltd, Ely Lilly Pharmaceuticals, Pfizer Pharmaceutical. Grants/research support; Gilead Sciences Ltd. S. Robinson: None. J. Barry: Corporate appointments; Gilead Sciences Ltd. P. Punter: Corporate appointments; Gilead Sciences Ltd. S. Kearns: Corporate appointments; Gilead Sciences Ltd. I. Goff: None.
BACKGROUND:Prior to commencing methotrexate, patients routinely attend an education consultation with a rheumatology nurse. The purpose of the consultation is to discuss the patients' expectations and concerns related to commencing methotrexate, the benefits of treatment, potential side effects and monitoring requirements. The aim of this study was to use video analysis to assess the structure, content and mode of delivery of the consultation.METHODS:Video recordings of 10 patient-nurse consultations, involving four specialist rheumatology nurses, were analysed and transcribed. The consultations were compared with the Calgary-Cambridge (CC) consultation model. Transcripts were thematically analysed. Data were quantitatively assessed for verbal and non-verbal behaviours.FINDINGS:Assessment of the video data using the CC model demonstrated good structure, content and flow of the consultation, influenced by the use of an information leaflet. Consultations generally consisted of communication from nurse to patient rather than a dialogue; the nurse spoke for 69%-86% of the time; clarification of the patient's understanding of the information did not take place in any of the consultations. Thematic analysis also showed that the nurse agenda dominated and the nurse was aware of 'overloading' the patient with information. Cues from the patients to discuss items of importance were often missed.CONCLUSION:Video analysis can be used to identify the aspects of the consultation that work well and those areas of the consultation that could be improved with specific training.